D-0148-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2017
- Initiation Date
- August 17, 2017
- Termination Date
- April 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 61 Products
Product Description
All Sterile Products within expiry
Reason for Recall
Lack of Assurance of Sterility .
Distribution Pattern
Nationwide.
Code Information
Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products